NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today co-primary endpoint results from a recently completed post-marketing required safety study, ORAL Surveillance (A3921133; NCT02092467). The primary objective of this study was to evaluate the safety of tofacitinib at two doses (5 mg twice daily and 10 mg twice daily) versus a TNF inhibitor (TNFi) in subjects with rheumatoid arthritis (RA) who were 50 years of age or older and had at least one additional cardiovascular (CV) risk factor.
The co-primary endpoints of this study were non-inferiority of tofacitinib compared to TNFi in regard to major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC)). Results showed that for these co-primary endpoints, the prespecified non-inferiority criteria were not met for the primary comparison of the combined tofacitinib doses to TNFi. Based on the prespecified secondary comparisons, there was no evidence of a difference in the primary endpoints between the two tofacitinib treatment groups.
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